FDA.reportPublic FDA data

RISERVA

Primary DI
G378BASNGPF30021
Brand
RISERVA
Company
Mohawk Hospital Equipment, Inc.
Model
BASNGPF30021
Catalog number
BASNGPF3002
Device description
RISERVA NITRILE EXAMINATION GLOVES MEDIUM CASE OF 2000
Published
2023-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110981000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G378BASNGPF30021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013326384
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G378BASNGPF30011RISERVABASNGPF30011BASNGPF30012023-03-10
G378BASNGPF30022RISERVABASNGPF30022BASNGPF30022023-03-10
G378BASNGPF30031RISERVABASNGPF30031BASNGPF30032023-03-10
G378BASNGPF30032RISERVABASNGPF30021BASNGPF30032023-03-10
G378BASNGPF30041RISERVABASNGPF30042BASNGPF30042023-03-10
G378BASNGPF30042RISERVABASNGPF30042BASNGPF30042023-03-10
G378BASVGPF40011RISERVABASVGPF40011BASVGPF40012023-03-10
G378BASVGPF40012RISERVABASVGPF40012BASVGPF40012023-03-10
G378BASVGPF40021RISERVABASVGPF40021BASVGPF40022023-03-10
G378BASVGPF40022RISERVABASVGPF40022BASVGPF40022023-03-10
G378BASVGPF40031RISERVABASVGPF40031BASVGPF40032023-03-10
G378BASVGPF40032RISERVABASVGPF40032BASVGPF40032023-03-10
G378BASVGPF40041RISERVABASVGPF40041BASVGPF40042023-03-10
G378BASVGPF40042RISERVABASVGPF40042BASVGPF40042023-03-10
G378BASNGPF30012RISERVABASNGPF30012BASNGPF30012023-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22
00850084857362MedClickMedClick LLCLZA2026-07-22
00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06